Improvement of frequency and severity of symptoms of eye
dryness, itchiness, and scratchiness also seen

BEDFORD, Mass.--(BUSINESS WIRE)--Dec. 14, 2015--
Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company
focused on the development and commercialization of innovative therapies
for diseases and conditions of the eye, today announced topline results
from a Phase 2 exploratory clinical trial designed to evaluate a range
of objective and subjective measures (signs and symptoms, respectively)
for DEXTENZA™ (sustained release dexamethasone) Intracanalicular Depot
for the treatment of inflammatory dry eye disease. This trial was
intended to explore which measures would be appropriate to include in
the design of a future clinical trial to evaluate efficacy of DEXTENZA
or other molecules in a sustained release product as a potential therapy
for dry eye disease.

The Phase 2 exploratory clinical trial was a prospective, multicenter,
randomized, parallel-arm, bilateral, double-masked, vehicle controlled
study to explore the safety and efficacy of DEXTENZA for the treatment
of subjects exhibiting signs and symptoms of moderate to severe dry eye
disease. The trial was conducted at two sites in the United States that
included 43 patients (86 eyes) and was not powered for statistical
significance. Designed as a serial phase study, patients were initially
administered a placebo vehicle depot for 45 days to establish a baseline
for the investigational drug treatment. Patients who responded to the
placebo vehicle depot, i.e., showed benefit from punctal occlusion
alone, were excluded from the treatment phase of the study. Qualifying
patients who continued to exhibit signs and symptoms of dry eye during
the initial 45 days were enrolled in the treatment phase of 30 days,
randomized to receive either DEXTENZA or a placebo vehicle in a 1:1
ratio.

In this trial, patients were selected for a minimum threshold of signs
of corneal staining and were randomized to either treatment with
DEXTENZA or a placebo vehicle depot. Patients were stratified into
groups based on the level of National Eye Institute aggregate corneal
fluorescein staining score improvement and were then randomized into the
treatment or placebo vehicle depot group per a pre-determined
randomization list to maintain masking. DEXTENZA treated patients showed
clinically meaningful benefits compared to patients receiving a placebo
vehicle depot, with improvement in total and inferior corneal staining
as well as conjunctival staining. While the study was not designed to
show statistical significance, total corneal staining at day 30
following randomization was significantly decreased from baseline in the
DEXTENZA group (-3.14) compared to placebo (-1.10) (p=0.018). Inferior
staining showed clinically significant differences in the change from
baseline in the DEXTENZA treatment group compared to placebo (-0.43 and
-0.45 at Day 15 and Day 30 respectively). Corneal staining is a primary
endpoint that has been used in recent phase 3 dry eye clinical trials
conducted by other ophthalmology companies for dry eye disease.
Supportive analyses of lissamine green staining also demonstrated a
clinically significant change in favor of DEXTENZA, where total staining
was more than 1 point improved for the DEXTENZA group compared to the
placebo.

While patients in this trial did not have a specific inclusion threshold
for symptoms of dry eye disease at the time of randomization, changes
from baseline to Day 15 and Day 30 in frequency and severity of symptoms
of eye dryness, itchiness, and scratchiness, as measured by the standard
patient evaluation of eye dryness (SPEED) questionnaires were noted to
favor the patient groups treated with DEXTENZA. There were certain other
measures included in the trial where DEXTENZA did not show a benefit
over the placebo group. The trial was designed to include many different
measures and identify those measures where DEXTENZA showed a benefit
compared with the placebo vehicle depot group to inform the design of
future clinical trials. The trial achieved this objective.

“We are encouraged that DEXTENZA showed improvements in the important
and highly relevant efficacy measures of total and inferior corneal
staining in this exploratory study. It is apparent that DEXTENZA
exhibited a global effect across all regions on the cornea, particularly
the inferior region, which is generally considered to be the most
susceptible region of the cornea for the onset of dry eye disease,” said
Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman of
Ocular Therapeutix, Inc. “We intend to advance this important clinical
program to expand DEXTENZA’s potential for this highly unmet need.
Inflammatory dry eye is one of the most common ophthalmic disorders
affecting approximately 20 million people in the United States, for
which novel treatments are needed. With the results from this
exploratory trial, we are now positioned to pursue the further
development of DEXTENZA for inflammatory dry eye disease.”

"Subject to further clinical testing, DEXTENZA may be able to satisfy an
unmet need for our patients with dry eye disease with its dual mechanism
of action, preservative free formulation, and rapid onset efficacy with
minimal compliance or safety concerns," stated John Sheppard, M.D.,
M.M.Sc., Principal Investigator, Virginia Eye Consultants (Norfolk, VA)
and Professor of Ophthalmology, Eastern Virginia Medical School
(Norfolk, VA).

This initial exploratory dry eye study has helped to identify and
concentrate the optimal patient population for sign responders.
Additional work will be done to identify and concentrate the proper
study population for symptoms responders.

While safety data continues to be analyzed, overall DEXTENZA had a good
safety profile and was well tolerated. There were no intraocular
pressure spikes noted in the trial. The retention rate of the drug
depots was 96% through day 30 of the treatment phase of the trial.

About DEXTENZA

DEXTENZA is a product candidate administered by a physician as a
bioresorbable intracanalicular depot and designed for extended drug
release to the ocular surface for 30 days. Ocular Therapeutix is
developing DEXTENZA for a broad range of front of the eye conditions. In
September 2015, the Company filed an NDA with the Food and Drug
Administration (FDA) for DEXTENZA for the treatment of post-surgical
ocular pain and a PDUFA date of July 24, 2016 has been set by the FDA.
The Company is conducting a third Phase 3 clinical trial to potentially
broaden its indication to include post-surgical ocular inflammation and
pain. After a successful initial Phase 3 study for the treatment of
allergic conjunctivitis, a second Phase 3 clinical trial is currently
enrolling for DEXTENZA for this additional indication.

About Dry Eye Disease

Dry eye disease affects the ocular surface and is characterized by
dryness, inflammation, pain, discomfort, and irritation. Dry eye is a
complex, multifactorial disease which can present differently in
patients, and becomes more common with age. Due to the prevalence of the
disease, over $1.5 billion was spent on treatment of the disease in the
United States alone in 2014 in both prescription and artificial tear
products (IMS Health). One cause of the disease is inflammation of the
ocular surface resulting from a patient’s immune response. Although
physicians may prescribe topical steroid eye drops for the treatment of
dry eye disease, chronic use of topical steroids can lead to elevations
in intraocular pressure, which is a risk factor for glaucoma. DEXTENZA
only contains approximately 7% of the amount of active dexamethasone
compared with eye drop therapy, resulting in an improved safety profile.
Conversely, patients often do not reliably self-administer these drops,
which can lead to eye irritation and continual, if not more,
inflammation.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company
focused on the development and commercialization of innovative therapies
for diseases and conditions of the eye using its proprietary hydrogel
platform technology. Ocular Therapeutix's lead product candidate,
DEXTENZA™, is in Phase 3 clinical development for post-surgical ocular
inflammation and pain and allergic conjunctivitis, and in Phase 2
clinical development for inflammatory dry eye disease. An NDA for the
post-operative ocular pain indication has been submitted to the FDA and
a third Phase 3 clinical trial is being conducted for post-operative
ocular inflammation and pain. The Company’s product candidate, OTX-TP
(sustained release travoprost) intracanalicular depot, has completed a
Phase 2b clinical trial for glaucoma and ocular hypertension. Ocular
Therapeutix is also evaluating sustained-release injectable anti-VEGF
drug depots for back-of-the-eye diseases. Ocular Therapeutix's first
product, ReSure® Sealant, is FDA-approved to seal corneal
incisions following cataract surgery.

Forward Looking Statements

Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about the
development or potential commercialization of the Company’s product
candidates, such as the Company’s clinical development of DEXTENZA for
the treatment of inflammatory dry eye disease, the Company’s plans and
expectations regarding regulatory submissions and the design and conduct
of a third Phase 3 clinical trial of DEXTENZA™ for post-surgical
inflammation and pain, the timing and conduct of a second Phase 3
clinical trial of DEXTENZA for the treatment of allergic conjunctivitis,
the timing and conduct of the Company’s additional development work and
clinical trials of OTX-TP for the treatment of glaucoma and ocular
hypertension and the ongoing development of the Company’s sustained
release hydrogel depot technology, the advancement of the Company's
other product candidates, the potential utility of any of the Company’s
product candidates and other statements containing the words
"anticipate," "believe," "estimate," "expect," "intend", "goal," "may",
"might," "plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," and similar expressions,
constitute forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements as a
result of various important factors. Such forward-looking statements
involve substantial risks and uncertainties that could cause the
Company’s clinical development programs, future results, performance or
achievements to differ significantly from those expressed or implied by
the forward-looking statements. Such risks and uncertainties include,
among others, those related to the timing and costs involved in
commercializing ReSure® Sealant, the initiation and conduct
of clinical trials, availability of data from clinical trials and
expectations for regulatory submissions and approvals, the Company’s
scientific approach and general development progress, the availability
or commercial potential of the Company’s product candidates, the
sufficiency of cash resources and need for additional financing or other
actions and other factors discussed in the “Risk Factors” section
contained in the Company’s quarterly and annual reports on file with the
Securities and Exchange Commission. In addition, the forward-looking
statements included in this press release represent the Company’s views
as of the date of this release. The Company anticipates that subsequent
events and developments will cause the Company’s views to change.
However, while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so. These forward-looking statements
should not be relied upon as representing the Company’s views as of any
date subsequent to the date of this release.

The use of this Site is governed by its Terms of Use. The information contained in this Site is for informational purposes only. It is not a substitute for professional medical advice and should not be used to diagnose or treat any medical or health condition.

The contents of this Site are subject to change without notice. Ocular Therapeutix may modify and/or discontinue operation of all or portions of this Site at any time at its sole discretion without notice, and assumes no responsibility to update this Site. Ocular Therapeutix makes no representations or warranties with respect to the use of this Site or any information obtained herein.